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Process Professional, Aseptisk Produktion

hace 1 semana

Departamento de Deseado, Argentina Alk-Abelló AS A tiempo completo

Brænder du for produktion af aseptisk fremstillet lægemidler og har du et kvalitets- og compliance mindset?
Vil du være med til at sikre levering, compliance og kvalitet i produktionen af allergivacciner – nu og i fremtiden? ALK er en virksomhed, som bygger på knap 100 års videnskabelig forskning og udvikling.
Vi er i dag verdens førende producent af allergiimmunterapi, og det er vores mål at udvikle og producere patientvenlige og veldokumenterede løsninger, så flere kan få gavn af behandling.
Som Process Professional vil du spille en afgørende rolle i at sikre levering af vacciner, ved at vores processer og udstyr er optimale og opfylder myndighedskravene indenfor aseptisk produktion.
Stillingen
Som Process Professional, vil du spille en afgørende rolle i at sikre, at vores produktionsprocesser og udstyr opfylder myndighedskrav.
Du vil blive del af teamet Process Support and Complex Cases, som består af 15 medarbejdere.
Teamets ansvar:
1st og 2nd line support til produktionen (fremstilling af bulks og fyldning i vials).Deltagelse i ALK's strategiske projektaktiviteter for fortsat at kunne levere til patienterne iht.
gældende myndighedskrav.Sikre at afdelingen altid er inspektionsklar, samt deltagelse i audits/inspektioner.Din primære funktion vil i starten være at supportere vores processer med direkte og dagligt samarbejde med fremstillingsoperatørerne.
Du vil modtage træning og uddannelse i vores processer, produktionsmiljø og cGMP, og du vil blive støttet af dine kollegaer, så vi hjælper til at du bliver en succes.
Du vil løbende få mulighed for at tilegne dig flere kompetencer, og derved også andre typer opgaver.
Produktionens åbningstid er i hverdagene fra kl.
6-17 suppleret med få planlagte weekenddage i løbet af året.
Arbejdsdagene er varierende, nogle dage vil derfor være tempofyldte, hvor det kræver hurtig aktion og samarbejde på tværs af teams, og andre dage vil der være mere plads til fordybelse samt mulighed for optimering af proces, produktion og kvalitet.
Det er derfor vigtigt for os at hjælpe hinanden i hverdagen og have et godt kollegaskab.
Arbejdsopgaverne er varierende og indebærer blandt andet:
Daglig support af produktionen og guidance til operatørerne.Håndtering af hændelser.Afvigelses- og Change control håndtering inkl.
implementering af aktioner.Håndtering af CAPA og Effectiveness Evaluations.Opdatering af PROF, SOP'er og WIN'er.Medansvarlig for gennemførelse af Aseptisk Proces Simulering (APS).Deltagelse i projektarbejde.Træning af kollegaer.Har du erfaring med nogle af nedenstående områder, er det en fordel, men ikke et krav:
Rengørings-, Steril- og Procesvalidering (CV/SV/PV)UdstyrskvalificeringRisikovurderinger (FMECA)Projektdeltagelse i større tværgående projekter.Din profil
Vi forestiller os, at du har en relevant videregående naturvidenskabelig uddannelse som f.eks.
ingeniør, farmaceut eller kemiker, samt stor interesse for aseptisk produktion.
Kendskab til aseptiske arbejdsmetoder og fremstilling af sterile lægemidler.Et solidt kvalitets- og compliance mindset.Erfaring med Systematisk Problemløsning til afvigelsessager.Trives i en travl og omstillelig hverdag og kan bevare overblikket i spidsbelastninger.Tager ejerskab og har fokus på at afslutte egne sager rettidigt og i rette kvalitet.Tilstedeværelse i produktionen - "Go to Gemba" - er naturligt for dig.Har en åben forståelig kommunikationsform og mestrer dansk og engelsk flydende mundtligt og skriftligt.En positiv indstilling, godt humør og god humoristisk sans.Kan opbygge og vedligeholde et bredt netværk i organisationen.Bliv en del af ALK
Hos ALK er det dine evner, ambitioner og dedikation, der hjælper os med at forbedre livet for patienter med allergi over hele verdenen.
Til gengæld tilbyder vi dig muligheden for at arbejde sammen med kompetente kollegaer og vi tilbyder dig en bred vifte af muligheder indenfor både faglig- og personlig udvikling.
Vi tilbyder et dynamisk og behageligt arbejdsmiljø med inspirerende og udfordrende arbejdsopgaver.
Du vil blive del af en engageret og uformel afdeling, som fokuserer på levering, kvalitet, kompetencer og udvikling.
ALK er en helbredsfokuseret organisation og vores kontorer er placeret i den naturskønne DTU Science Park i Hørsholm, med en fremragende personalerestaurant.
ALK er en del af DTU Science Parks personalefælleskab, der tilbyder en bred vifte af sociale arrangementer og klubber, sammen med medarbejdere fra omkringliggende virksomheder, året rundt.
Vil du vide mere om vores virksomhed, opfordrer vi dig til at besøge os på www.alk.net.
Ansøg
Har du lyst til at blive en del af vores team, så send dit CV og kort beskrivelse af din motivation for stillingen, snarest muligt og senest den 30. marts 2025.
Vi forpligter os til en inkluderende rekrutteringsproces og lige muligheder for alle vores jobansøgere.
Vi vurderer ansøgninger og indkalder til samtaler løbende, så vent ikke med at søge
Vi forbeholder os retten til at tage annoncen ned, når vi har fundet den rette kandidat.
Har du spørgsmål til stillingen kan du kontakte Manager, Lars Nislev på telefon +45 27 83 44 35.
Vi frabeder os venligst, at headhuntere og rekrutteringsbureauer kontakter os vedrørende denne stilling.

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